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Arterial Vascular Engineering Massachusetts, Inc.

USA · Billerica

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class IV 2

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 4 510(k), 0 PMA, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: MEDTRONIC AVE (ARTERIAL VASCULAR ENGINEERING INC.

Same-named companies — This database also contains companies with near-identical names: Arterial Vascular Engineering, Inc., MEDTRONIC AVE (ARTERIAL VASCULAR ENGINEERING INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K984482	AVE GL-1 GUIDING CATHETER	1999-07-30
US	K984627	AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER	1999-07-27
US	K983927	GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT	1999-03-11
CA	9270	AVELTX PTCA BALLOON DILATATION CATHETER	Class IV
CA	10654	MICRO STENT II RAPID EXCHANGE DELIVERY SYSTEM AND MICRO STENT II XL RAPID EXCHANGE DELIVERY SYSTEM	Class IV

Arterial Vascular Engineering Massachusetts, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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